CLEVELAND, Ohio-- A Cleveland Clinic researcher who has spent the past 11 years working on a breast cancer vaccine that would both prevent the disease and keep it from recurring has secured enough funding to move the drug to clinical trials.

Vincent Tuohy, an immunologist at the Clinic's Lerner Research Institute, will head up the company, called Shield Biotech, as its chief science officer. Shield Biotech, so named because the vaccine it is developing will act as a defense against breast cancer, is a spinoff-company created by Cleveland Clinic Innovations, the commercialization arm of the hospital system.

A private investor, who wishes to remain anonymous, is providing the funding for the initial clinical trials, but the Clinic would not provide the exact amount of the donation.

Recruited by the Clinic in 1989 for his research in multiple sclerosis, Tuohy first published promising research results from the vaccine in 2010 in the journal Nature Medicine. Those results, which garnered international attention, showed that a single vaccination against a protein called alpha-lactalbumin prevented breast cancer tumors from forming and halted the growth of existing tumors in mice.

Alpha-lactalbumin, which in healthy women is a protein that is found only in the breast milk, is also produced in tumor tissues, for reasons that are not yet fully understood.

"In a way it doesn't matter [why]," Tuohy, 65, said. "What we really care about is that we can take advantage of it and actually provide immune protection to stimulate a woman's immune system so that she doesn't get breast cancer."

The vaccine would target the alpha-lactalbumin protein for destruction in older women, but could probably not be used on lactating women or women who might become pregnant. Researchers tested the vaccine on lactating mice, Tuohy said, and it didn't kill them, but it did inflame the breast tissue.

The target in breast cancer patients would be in women where the protein is no longer naturally expressed, he said.

"When [the protein] does appear in the aging woman, it is only trouble," he said. "The only time that we anticipate the immune system will see this protein is when a tumor emerges."

Shield Biotech will now take up the task of seeking FDA permission to begin small-scale clinical trials of the vaccine, a process that will probably take two years.

The two Phase 1 trials would involve about 100 patients, and will be designed to test the safety of the vaccine and dosage, toxicity and immune response. The first would test the safety of the drug in women who have recovered from treatment for triple negative breast cancer, a highly-lethal form of the disease that often recurs.

In the second trial, researchers will test the vaccine on women with a high predisposition for developing breast cancer, usually those who have inherited a mutated BRCA gene. Many of the women with these mutated genes elect to have voluntary mastectomies to cut down their risk of cancer, which can be as high as 80 percent.

In the trial, women with the mutated gene will receive the vaccine a few months before the planned mastectomy, and researchers will examine the breast tissue once it is removed to see if there is any damage.

Tuohy said it may take three years to complete the trials, and the start date is two years away. "We're 10 years out from seeing this available for women," he said.

Since publishing the initial results in mice, Tuohy's research group has been on a long and frustrating search for the formidable amount of funding it takes to move such a discovery from the laboratory to the patient.

The cost to produce the vaccine is estimated to exceed $1 million, and the total cost of conducting a trial approved by the Food and Drug Administration is more than $6 million.

Tuohy's lab was turned down for several sizable grants from the National Cancer Institute (part of the National Institutes of Health), the Department of Defense Breast Cancer Research Program, and Susan G. Komen for the Cure.

"I've personally experienced a great level of anxiety and futility in trying to get this funding," said Tuohy. "It's really difficult to change mindsets, and the current mindset is that we wait for the cancer to recur and then we beat the daylights out of it with all these abrasive, toxic approaches. I'm not opposed to that, but we need a defense as well."

"I can't express how delighted I am that we now have these resources," he said. "I really got through this period because of all the women out there who have been so supportive of this research. It's really their vaccine."

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